My client is a global leading medical device organisation that has been a long time investor here in Ireland since the 1960's. Employing in the region of 70,000 employees globally and with revenue north of 16 billion per annum, this medical device organisation remains one of the largest and most innovative worldwide. Since its introduction to Ireland, this innovator has proceeded to continuously invest in this country with investments in additional manufacturing and research sites across Ireland. One of the organisations' primary plants is based in South Dublin and is currently undergoing significant investment and change. It has transformed its operations in Ireland through strong leadership, continuous innovation and demonstrating the importance of this site to the organisations global manufacturing operations. At present, a requirement exists for a Senior Quality Engineer - Sustaining to join its expanding operation here in Dublin.
The Senior Quality Engineer will be accountable for supporting new product development and ongoing Product Life Cycle technical and engineering support through the application of Quality engineering skills for medical devices.
In this role, some of the responsibilities will include:
- Design Control
- Change control
- Risk Management
- Process Validations
- Identification of CTQ's
- Unit Quality Independent Reviewer During Design Reviews
- Handling of deviations and non-conformances
- Test method validations
- Supplier qualification
- Software validations
- Post Market Surveillance
- Situation Analysis
- CAPA - Root cause investigation and implementation of corrective / preventive actions
The successful candidate will possess:
- Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, and ISO 13485 / ISO 14971
- Experience in the medical device industry with knowledge in the area of customer relations, complaint trending, FDA regulations, GMP and clinical laboratory functions.
- Certified Quality Engineer and Certified Quality Auditor (preferred).
- Training in design of experiments and statistics. Class II / III medical device experience.
To learn more about this role apply online or call Helena Boyle on + 353 1 6321870 or 0873360953 for a confidential discussion.